Health Condition 1: I998- Other disorder of circulatory system
Conditions
Interventions
Intervention1: Vegetable powder Capsules (VP70) 400 mg: Two capsules at a time, per day for 84 days.
Control Intervention1: PLACEBO: Two capsules at a time, per day for 84 days.
Sponsors
ITC Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Males and females of age group 18-60 years • Patients with diabetes (FBS greater than or equal to 130 mg/dL , PPBS greater than or equal to 200 mg/dL) • Obese patients with Body mass index 25 to 35 kg/m2. • Patients prone to Cardiovascular disease (Triglycerides greater than or equal to 150 mg/dl) • Subjects must understand risks and benefits of the protocol and be able to give informed consent along with audio video visual. • Equal distribution of subjects receiving medication amongst the test and placebo arms
Exclusion criteria
Exclusion criteria: • History of thyroid diseases • History of HIV positive patients • Pregnant or lactating woman • Cancer, smoking, alcohol drinking.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Management of Cardiovascular risk factors (Changes in the Triglycerides)Timepoint: Screening to visit 5( Day 84) | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life questionnaire Changes in the FBS,PPBS Changes in the ECG, Lipid Profile, LFT, KFT, HbA1c, BMI, Weight, anthropometric measures. Incidence and rate of adverse events Blood pressure,PP Triglycerides Timepoint: Screening to Visit 5(Day 84) | — |
Countries
India
Contacts
Public ContactDr Harisha S
ICBio Clinical research Pvt Ltd
Outcome results
None listed